Working Title:Intensification of experimental design for Escherichia coli fed-batch fermentations

Project description: To release new biotherapeutics statistical Design of Experiments (DoE) possesses a key role in the quality-by-design (QbD) implementation for advanced process understanding and control in the context of the US Food and Drug Administration’s PAT/QbD guide (2004). However, this meaningful data generation is often time-consuming. Therefore, in this project an approach to accelerate the data generation and thereby reduce the time-to-market, while maintaining the required product quality levels, is applied using an E. coli strain in fed-batch mode expressing a model protein.

Workflow:Your main focus will be on the fed-batch fermentations, including preparation, execution and sampling, as well as the analyses in the postprocessing for process variables like biomass and product titer quantification. These results will be used to build models and evaluate their performance compared with a static experimental design.